A Bayer drug designed to target tumors driven by a rare genetic mutation now has accelerated FDA approval , providing another treatment option for certain patients with advanced cases of lung cancer.
The Wednesday regulatory decision for the Bayer drug, sevabertinib, covers the treatment of adults whose locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) has tumors with HER2 (also called ERBB2) mutations. In addition to carrying this mutation, patients eligible for Bayer’s drug must have cancer that has advanced after at least one prior line of systemic therapy. Alongside the approval of the drug, which will carry the brand name Hyrnuo, the FDA also approved a Life Technologies companion diagnostic to identify patients who may be eligible for treatment with Ba

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